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The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided FDA 510(k) Clearance Letter for the "SnapHammer Hammertoe Correction System" describes a medical device, specifically a metallic bone fixation fastener. This document is a regulatory clearance for a physical medical device, not a software or AI-based medical device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI/software medical device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth, training set information) is not applicable to the provided document.

The document states:

• "No FDA performance standards have been established for the SnapHammer Hammertoe Correction System."
• The non-clinical testing performed focused on:
  • "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
  • "The steam sterilization process has been validated per ISO 17665-1 & 17665-2 to a sterility assurance level of 10⁻⁶"
• The basis for equivalence is that the device "maintain[s] the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method."
• "This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence."

In summary, this clearance is for a physical orthopedic implant and is based on demonstrating substantial equivalence to a predicate device, primarily by showing that a new sterilization method does not alter its safety or efficacy, rather than AI/software performance metrics.

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The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

This document is a 510(k) premarket notification for a medical device called the "SnapHammer Hammertoe Correction System." It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it provide a table of acceptance criteria and reported device performance directly related to an AI/Software as a Medical Device (SaMD) product.

Instead, this document describes a hardware medical device (a bone fixation fastener) and the non-clinical (mechanical) testing performed to demonstrate its safety and efficacy.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance for an AI/SaMD.
• Sample size used for a test set or data provenance for an AI/SaMD.
• Number of experts or their qualifications for establishing ground truth for an AI/SaMD test set.
• Adjudication method for an AI/SaMD test set.
• MRMC comparative effectiveness study results.
• Standalone performance for an AI/SaMD.
• Type of ground truth used for an AI/SaMD.
• Training set sample size or how its ground truth was established for an AI/SaMD.

The document discusses "non-clinical testing" for the orthopedic implant, which includes:

• Mechanical Performance: Torsion, driving torque, and axial pullout (per ASTM F543), as well as static and dynamic bending.
• Additive Manufacturing: Tensile testing per ASTM F3001 and residual powder removal (particle analysis per ASTM F1877).

It concludes that based on these tests, the device does not raise new issues of safety or efficacy compared to the predicate devices. This implies that the acceptance criteria for these mechanical tests were met, demonstrating equivalence. However, the specific quantitative acceptance criteria or results for these mechanical tests are not detailed in this publicly available summary.

In summary, this document is about a physical medical device (hardware) and its mechanical testing, not a software or AI-based medical device. Therefore, the requested information regarding AI/SaMD acceptance criteria and study design is not present.

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The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint ● disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion

The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

The provided text is a 510(k) summary for the Xenix Medical Sacroiliac Fixation System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not describe the acceptance criteria and the study that proves the device meets those acceptance criteria in the context of an AI/ML medical device. The information requested in the prompt, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy), sample size for test sets (along with data provenance), expert ground truth establishment, MRMC studies, or standalone algorithm performance, is completely absent from this document.

The performance testing described here is for mechanical properties, sterilization, bacterial endotoxin, and navigation instrument accuracy, which are typical for traditional hardware medical devices like orthopedic fixation systems, not AI/ML algorithms.

Therefore, I cannot provide the requested information based on the given input. The device referred to in the document is a physical implant and surgical instrumentation system, not an AI/ML-driven diagnostic or therapeutic device.

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The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

The Integral Titanium Cervical Interbody is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are additively manufactured using titanium alloy per ASTM F3001.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.

This document is a 510(k) Summary for the Integral Titanium Cervical Interbody and does not contain any information regarding clinical studies, acceptance criteria, or performance data related to AI/algorithm performance.

The document describes a medical device, an intervertebral body fusion device, and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. The listed tests are engineering and mechanical tests (e.g., static and dynamic compression, subsidence, expulsion) to assess the physical properties and safety of the implant itself, not its diagnostic or decision-making performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device's performance, as this information is not present in the provided text. The document focuses solely on the substantial equivalence of a physical medical implant based on its design, materials, and mechanical testing results.

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